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Ethical Vignettes in Reproductive Health

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           ETHICAL VIGNETTES IN REPRODUCTIVE HEALTH

                            By Naira R. Matevosyan, MD, PhD
                           Copyright © 2011-2016 Naira R. Matevosyan



SUMMARY: Present meta-study elucidates country-based ethical priorities in reproductive health. A
total of 96 sources published in 1986-2011, and suitable for level of evidence (I-IIA), are identified
through PubMed portal. Pooled prevalence of bioethical problems, their determinants, and outcomes
are modeled as measurable outcomes. Ethical debates are correlated with extrapolated maternal and
perinatal mortality rates from salient obstetrical data. Results suggest that ethical principles are not
equally discussed (Cochran's Q 65.08). 50% of studies present two or more ethical debates.
Beneficence and nonmaleficence are strongly associated (Pearson's chi 56.12, p < 0.002). Correlations
fail to display associations between ethical issues, and country-based perinatal mortality rates (0.117 -
0.209). Patient`s autonomy, adolescent's pregnancy, fetal surgery, cross-boarder reproduction,
surrogacy, stem cell registry, and reproductive health in mentally ill, remain poorly seen or addressed
ethical debates in reproductive health.

KEYWORDS: Maternal-fetal conflicts, In-vitro fertilization, Posthumous reproduction, Stem cell
research and registry


                                            CONTENT:

                   I.     Problem Definition                         Page 3

                   II.    Methods                                    Page 5

                   III.   Data Extraction & Analysis                 Page 6

                   IV.    Results                                    Page 6

                   V.      Discussions                               Page 11

                   VI.     Conclusions                               Page 13

                   VII.    Implications for Research                 Page 13

                   VIII. Works Cited                                 Page 14
                                               Page 3 of 18

       I. PROBLEM DEFINITION: Reproductive health providers commonly confront complex

ethical questions that can be answered only through thoughtful consideration of values, interests, rights,

and obligations of those involved [1]. Providers struggle daily with tough decisions that arise in serving

previable patient, adolescents, counseling HIV-positive clients and victims of domestic violence. No

society, no culture, no religion, and no statutory or case law has been neutral about ethical issues of

human reproduction and maternal-fetal conflicts. While ethical principles cannot dictate solutions to

problems that arise from a genuine lack of resources, they do indicate solutions to preventable

problems. Such universal ethical principles include the principle of beneficence, which obligates people

to attempt to produce more good than harm.

       Universal ethical principles can be used to analyze problems in reproductive health. The

principle of beneficence obligates people to strive to bring about more beneficial consequences than

harmful ones. The principle known as respect for persons presumes that all human beings have dignity

and are worthy of respect. Showing equal respect for the pregnant woman and fetus as persons, means

recognizing their autonomy and treating them as capable decision-makers and full participants in

medical decisions. Another leading concern of bioethics is justice, which requires egalitarian

performance by the provider, and libertarian thinking by the patient. Statutory and case laws, policies,

and practices must be changed if they result in consequences more harmful than helpful.

       Ethical principles of public health are distinguishable from principles applied in modern

bioethics. At the risk of over-simplifying the difference between clinical ethics and public health ethics,

it could be said that the default position of clinical ethics centers on respect for the individual patient

and his/her autonomy, whereas the default position of public health ethics centers on the pursuit of the

collective or common good. By its very nature, public health aims first and foremost at promoting

population benefit and thus has a broadly 'utilitarian' orientation, which tends to place emphasis on
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maximizing overall 'output,' rather than to focus upon 'gain/lose' ratio at the level of the individual.

While public health ethical aspects of human reproduction concern reduction of unsafe abortion,

maternal mortality and morbidity most prevalent where abortion laws are restrictive [22, 24], bioethical

principles are developed at the clinical or microethical level affecting relations among individuals,

whereas pubic health ethics applies at population-based, macroethical level. Public health

recommendations are mostly derived from inter-disciplinary commissions that solicited public input in

that particular country or region [15]. For instance, the World Health Organization (WHO) defines

sterility as an illness, but a wast number of countries do not accept this definition [45].

       The role of biotheology is foremost to clarify for different religious communities perceived

attitudes toward these developments. Judaism and Islam allow the practice of assisted reproduction

when the oocyte and sperm originate from the wife and husband, respectably. The practice of assisted

reproduction is not accepted by the Vatican, but is allowed by Protestant, Anglican, Lutheran, and

other Denominations. All Rabbinical rulings permit the use of contraception for medical indications.

Judaism forbids abortion on demand but allows therapeutic abortion. The Christian tradition views the

embryo as a human being since conception and therefore, abortion and contraception are strictly

forbidden [76]. Equilibrium can be best achieved by nurturing interdependent relationships that

empower and protect the vulnerable women, including those with mental illnesses [26].

       Women with serious mental illnesses, or illicit substance users, may be unable to understand

and consent for reproductive health interventions. Evidence suggests that women with schizophrenia

and mood disorders have reduced fertility, more lifetime sexual partners, high rates of unwanted

pregnancies, fewer planned pregnancies and live births, severe parenting difficulties, and are at

significantly enhanced risk for HIV infection [57]. About 50% of mentally ill women are sexually

active, and 43% among the moderately retarded women become pregnant. The intellectual impairment
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and stigma among mentally ill prolong and challenge their gynecological counseling and examination.

        Practitioners often confront the question whether or not they have to employ the method of

advanced decisions by the third party in management of reproductive health issues in mentally ill

patients. However, in many cases the concept of the 'reproductive health' is being misunderstood.

Human reproduction cannot be viewed exclusively in its primordial goal, e.g. the perpetuation of the

species [27]. The WHO defines reproductive health as as a state of physical, mental, and social well-

being in all matters relating to the reproductive system at all stages of life. Implicit in this are the rights

of men and women to be informed and to have access to safe, effective, affordable, and acceptable

methods of family planning of their choice. Current study prioritizes major ethical debates in

reproductive health; surpasses ethical pluralism; and celebrates studies that are less focused on debates

and more focused on practical resolutions.

        II. METHODS: Ninety-six studies published in 1986-2011 are identified through PubMed and

are inclusive for relevance and level of evidence (I, II-1). Key monographs are hand-searched. There is

no restriction on language of studies. Pooled prevalence of ethical problems (patient's autonomy,

maternal-fetal conflicts, stem cell research, disclosure decisions, others), their approximate

determinants (health policy, religious constraints, infrastructure conflicts), and outcomes (maternal,

fetal, infant, and perinatal morbidity and mortality) are modeled as measurable outcomes. Current

evaluation covers a number of contradictions: abortion [7, 85, 94], maternal autonomy [6, 8, 11, 25, 32, 46,

60, 69], maternal-fetal conflicts, elective fetal surgery [54, 58], rights of previable/viable intrauterine

patient [14, 17], adolescents` pregnancy [5], disclosure decisions [35], emergency contraception [16],

reproductive technologies [65, 68, 74, 86, 90], in vitro fertilization [33, 38, 72], human enhancement

technologies [6], oocyte donation [52, 80], surrogacy [22, 67, 78, 81], gene therapy [93], stem cell research

and registry [39, 43, 47, 61, 62, 68, 71, 84], religion [28, 34, 75, 88], and public health ethics [2, 30, 67].
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       III. DATA ANALYSIS: Data are extracted for the associations between ethical principles and

clinical outcomes. Kruskal-Wallis analysis of variance (ANOVA) is used for the ranked ordinal data;

Chi-squared (X2) is used where data are categorical with a 95% confidence interval (CI) using a fixed

effects model. Generalized estimating equations are used with an exchangeable correlation structure

into which a Pearson model is fitted. Chronbach`s alpha is computed for the interclass construct

validity. Factors with intraclass-correlation (ICC) coefficient above 0.400 are considered as

comparative. Pooled estimates of ethical issues and practices per country are correlated with country-

based perinatal and maternal mortality rates extrapolated from salient obtstetrical data. Analyses are

performed using ASSISTAT (version 7.5 β, 2008) and EpiInfo (version 3.5.1).

       IV. RESULTS:        The U.S. researchers contribute in 60.4% of studies (n=58). Twenty two

studies are from Europe (n=22), in particular, from Belgium [61, 69, 70], Denmark [49], Finland [36, 65],

France [52, 68], Germany [43, 45], Ireland [58, 80], Poland [19], Romania [27], Spain [33], and the U.K [12,

25, 40, 59, 78, 85, 90]. Eleven studies are conducted in Canada (n=11) [10, 16-18, 21-24, 44, 76, 93] and nine

in Australia [64], Chile [76], Iran [95], Israel [71, 76], Japan [83, 87], Kenya [49], and Turkey [74]: (n=9).

Table 1 presents country-based ethical debates:

             Table 1: Country-based ditribution of ethical debates in reproductive health

Problem:                             U.S.A                Canada               U.K & EU        Oceania , Asia
                                                                                               & Elsewhere

Adolescent's pregnancy      Aruda (2008)                        -                    -               -

Autonomy                    Athar (2008) Balint      Cook (2009)            Pennings (2007)   Su (2005)
                            (2002) Bergeron (2007)   Seavilleklein (2009)
                            Donchin (2009)           Woodcock (2010)
                            Dudzinski (2006)
                            Goering (2009) Kukla
                            (2009) McLeod (2009)
Cloning                     Fiester (2005)                      -           Niemelä (2010)    Revel (2003)
                                                                            Pellerin (2002)
Client and provider         Balint (2005)            Cook (2002, 2006,               -               -
education in bioethics      Hill (1987)              2009)
                                                      Page 7 of 18

Disclosure decisions           Aruda (2008)                          -               -                  -
                               Hahn (2002)
Elective abortion              Adams (2002) Ballantyne Cook (2002, 2006,    McDonnell (2006)    Samtani (2009)
                               (2009) Clune (2009) Hill 2009) Dickens       Timpson (1996)      Zahedi (2008)
                               (1987) Walters (1986)    (2007) Woodcock
                                                        (2010)
Emergency contraception                      -            Cook (2006)                -                  -
                                                                                     -
Fetal surgery                  Lyerly (2001, 2007)                   -               -                  -
                                                                                     -
Gene therapy                   Park (2009) Wolf (2009)               -               -                  -
                                                                                     -
Informed clinical trials and Macklin (1995)               Woodcock (2010)   Czarkowski (2009)   Lema (2009)
consents                                                                    Lebech (1997)

In vitro fertilization (IVF)   Hill (1987)                Baylis (2003)     Dumitrache (1993)   Schenker (2000)
                               Rosenthal (2010)                             Gracia (1988)
                                                                            Niemelä (2010)
                                                                            Pellerin (2002)
                                                                            Pennings (2007)
Health insurance               Hall (2009)                           -               -                  -
limitations
Human enhancement              Athar (2008)               Krahn (2009)      Bostrom (2005)              -
technologies                   Park (2009)

Malpractice                    Davis (1997)               Cook (2009)                -                  -
                               Jones (1996)
                               Lyerly (2007)
Medicalization of              Bergeron (2007)                       -               -                  -
childbirth
Oocyte donation                              -                       -      Letur-Könirsch      Zahedi (2008)
                                                                            (2004) Sills (2008)
Procreative liberty            Cohen (1997)                          -      Pennings (2007)             -
                               Steinbock (1995)
Public health ethics           Agarwal (2007)           Dickens (2007)               -                  -
                               Anonymous (2000) Evans
                               (1993) Pellegrino (1987)
Religion                       Eberl (2009) Habgood                  -      McDonnell (2006)    Schenker (2000)
                               (1985)                                                           Ueda (2008)
                                                                                                Samtani (2009)
Reproductive health in         Dudzinski (2006)                      -               -
mentally ill or disabled       Lyerly (2001)                                                    Newell (2006)
                               Matevosyan (2009)
Rights of intrauterine         Ballantyne (2009)          Cook (2009)                -                  -
patient                        Clune (2009)               Dickens (2008)

Reproductive technologies Evans (1993) Turner             Baylis (2003)     McDonnell (2006)    Sahinoglu-Pelin
                               (2009)                     Dickens (2008)    Niemelä (2010)      (2002)
                                                                            Pellerin (2002)
                                                    Page 8 of 18

                                                                         Pennings (2007)
                                                                         Warnock (1987)
Surrogacy                     Hill (1987) Pellegrino    Dickens (2008)   Shenfield (2005)           -
                              (1987) Steinbock (1995)                    Sills (2008)
                                                                         Warnock(1987)
Stem cell research and        Balint (2002) ISCBI                  -     Kress (2006) Mertes Revel (2003)
registry                      (2009) Hyun (2010)                         (2009) Pellerin
                              Latham (2009, 2009)                        (2002)
                              Meyer (2009) Taymor
                              (2009)
Total research contribution   58 (47.5%)                22 (18.0%)       29 (23.7%):         13 (10.6%)
per country/ region:



       The number of studies included in Table 1 (n = 122) exceeds total number of reviewed studies

(n=96), as the majority of studies present more than one ethical debates. It can be seen that patient`s

autonomy (10.9%), elective abortion (11.7%), IVF (7.5%), and stem cell research (9.2%) remain the

major themes (95% CI, p<0.05). Adolescent pregnancy (0.8 %), emergency contraception (0.8%), fetal

surgery (1.7%), oocyte donation (2.5%), gene therapy (1.7%), human enhancement techniques (3.3%),

health insurance limitations (0.8%), malpractice (3.3%), medicalization of childbirth (0.8%), and

reproductive health in mentally ill or disabled (3.3%) are the least attended ethical issues in

reproductive medicine. The proportions of each ethical principle are tested against each other for

equality using Cochran's Q test; the Q test reaches statistical significance (65.08, df = 3, p < 0.0001)

indicating that the ethical principles are not equally discussed. Current review locates scant data on

cross-boarder reproductive care, and no data on maternal-fetal conflicts, pregnancy in terminally ill

patients, and advanced decisions for mentally ill.

       As shown in Table 1, the U.S and Canadian studies mostly capture ethical debates related to

patient`s autonomy (13.7%), abortion (12.5%), client and provider education (6.25%), malpractice

(5.0%), public health ethics (6.2%), and stem cell research and registry (8.7%), whereas the European

studies are more focused on reproductive technologies (17.2%), IVF (17.2%), oocyte donation (6.9%),
                                                 Page 9 of 18

surrogacy (10.3%), and stem cell research (10.3%). When examining both major and minor themes,

forty eight articles (50%) present two or more ethical principles. Beneficence and nonmaleficence are

strongly associated (Pearson's chi 56.12, df = 1, p < 0.002). Of the total abortion debates, 66.7% are pro-

choice (p< 0.015) [7, 14, 18, 24, 38, 58, 85, 89, 94, 96], 6.7% pro-life (p< 0.058)[75], and 26.7% pro-middle

(p< 0.02) [1, 16, 17, 83]. Seven studies discuss theological debates, of which two (28.5%) are related to

Catholicism [28, 34], two (28.5%) Judaism [28, 76], one (14.3%) Islam [95], one (14.3%) Hinduism [75],

and one (14.3%) Buddhism [87].

           Studies suggest on 17-22% pregnancy rates from transferred frozen-thawed embryos [France],

86%- after infertility treatment, 26% - from the cross-boarder fertility treatment [UK], 1.9%- from the

cryopreserved empryos allocated for research [Canada], 60% consent for posthumous reproduction

[Japan],   and 47% consent for fetal surgeries for nonlethal reasons [USA]. 77% of studies support that

innovative therapies, such as fetal surgeries, should be performed only under IRB-approved protocols

and 55.2 % indicate that these procedures have not been validated [USA]. 48.2% pregnant adolescents

opt to continue their pregnancy, 45% choose to terminate, and 6% have miscarriages. Adolescents who

continue their pregnancy have a significantly longer time interval to their referral site, averaging 24

days until a prenatal appointment, compared to 17 days for a termination [USA].

           Overall, studies are not informative enough on how and when ethical issues arise, do not assess

the epidemiological risk factors for ethical and legal problems that emerge in reproductive health, and

the role of parties inolved. Furthermore, the qualitative and quantitative ethical goals vary in different

countries and regions. Secular trends in ethics are difficult to interpret because of diverse social and

ethnic structure of the target countries. Therefore, current study presents country-based ethical

priorities. Figure 1 illustrates proportional weights of country-based major ethical debates:
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            Figure 1: Country -based distribution of ethical debates in reproductive health




         Pooled estimates of country-based ethical debates are extracted for further correlations with

extrapolated perinatal and maternal mortality ratios from obstetrical reports of various countries, as

presented in Table 2:

                             Table 2: Maternal/ perinatal mortality ratios


Country: Proportional weight      Maternal mortality *          Lifetime risk of    Perinatal mortality**
          of countries in the                                   maternal death*
               sample:            Incidence per 100,000         One incidence in:   Incidence per 1,000 live
                 n (%)                  live births                                          births
Australia         1 (1.03)                 4                        13,.300                   4.4
Belgium           3 (3.09)                 8                         7,.800                   4.2
Canada           11 (11.3)                 7                        11,.300                   4.8
Chile             1 (1.03)                 16                        3,.200                   7.2
Denmark           1 (1.03)                 3                        17,.800                   4.4
Finland           2 (2.06)                 7                         8,.500                   3.7
France            2 (2.06)                 8                         6,.900                   4.2
Germany           2 (2.06)                 4                        19, 200                   4.3
                                                   Page 11 of 18

Iran                1 (1.03)                 140                     300                       30.6
Ireland             2 (2.06)                  1                     47, 600                    4.9
Israel              2 (2.06)                  4                     7,.800                     4.7
Japan               2 (2.06)                  6                     11, 600                    3.2
Kenya               1 (1.03)                 560                      39                       64.4
Poland              1 (1.03)                  8                     10, 600                    6.7
Romania             1 (1.03)                  24                    3, 200                     14.9
Spain               1 (1.03)                  4                     16, 400                    4.2
Turkey              1 (1.03)                  44                     880                       27.5
UK                  7 (7.21)                  8                     8, 200                     4.8
USA                55 (56.7)                  11                    4, 800                     6.3
 Sources: * Monitoring the situation of children and women: UNICEF report, 2005
          ** Unite for children: UNICEF report, 2008

          As shown in Table 2 Kenya and Iran have the highest maternal and perinatal mortality ratios

and lifetime risk of maternal death. Ireland, Spain, Australia, and Japan report the lowest maternal and

perinatal mortality risks and ratios. Pearson correlations reveal non-significant associations between

ethical vignettes discussed in current review and maternal and perinatal mortality estimates: r2 = 0.138,

0.209, and 0.117, correspondingly. Correlations fail due to the small sample-size, and the abscence of

existing knowledge and reports on causes and conditions of each ethical dilemma that could be used as

an intervening variable of interest.

             DISCUSSIONS:
          V. DISCUSSIONS: Ethical problems (abortions, autonomy, IVF, stem cell research, disclosure

decisions), their approximate determinants (religious constraints, infrastructure conflicts), and

outcomes (maternal and perinatal mortality rates) presented in 96 studies published between 1986 and

2011, are modeled as measurable outcomes. Ethical debates are correlated with country-based maternal

and perinatal mortality rates through applying the Pearson method.

          Secular trends in maternal-infant health ethics are difficult to interpret because of diverse social,

and ethnic profile of target groups. The strength of these associations is small compared with impact of
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public health policies that vary in each country. 90.6% of studies present debates without practical

solutions. Human enhancement techniques, assisted and posthumous reproduction raise an immense

number of questions regarding the quality of health and life of the child born under these

circumstances. Patient's autonomy, adolescent's pregnancy, fetal surgery for nonlethal reasons, mental

and somatic health of child derived by human enhancement techniques, posthumous dignity, cross-

boarder reproduction, health insurance for assisted reproduction, medicalization of childbirth, stem cell

registry, and reproductive health in mentally ill remain the least attended ethical topics in reproductive

health.

          Correlations fail to find associations between presented ethical issues and country-based

maternal and perinatal mortality rates ( r2 = 0.117- 0.209). Current study defines and classifies

maternal-fetal conflicts:

          (I) Behavioral (vegetarian or low calorie diet in pregnancy, smoking, informed assent);

          (II) Psychosocial (serious mental illness, illicit drug use, smoking, alcoholism);

          (III) Environmental (exposure to hazards, vibration, noise, heavy metals, and bio-substances);
          (IV) Obstetrical (placentation defects);

          (V) Medical (preexisting medical conditions, sych as diabetes mellitus, hypertension, thyroid
dysfunction, cancer, lupus, vertically transmitted infections);

          (VI) Biological (Rhesus and LHA conflicts);

          (VII) Iatrogenic (diagnostic errors and malpractice);

          (VIII) Paternal (unwished pregnancy, financial instability, poor relationships and attachment);
          (IX) Legal (conflicts between infrastructures, such as the Supreme Court and State Laws);
          (X) Public health (conflicts between Committee Statements, such as American Academy of
Pediatrics, American College of Obstetricians and Gynecologists).

          Present review suggests that clinical pregnancy rate from the transferred frozen-thawed

embryos reaches 17-22%; 1.9% of cryopreserved empryos are allocated for research; 60% of couples
                                                Page 13 of 18

consent for posthumous reproduction; 47% consent for fetal surgeries for nonlethal conditions; 48.2%

pregnant adolescents choose to continue their pregnancy, 45% opt to terminate, and 6% have

miscarriages.

          Limitations: This study cannot afford enabling factor-outcome flotations: for instance, abortion

could be both cause and consequence of an ethical conflict. Next, there may be discrepancies in

definitions of perinatal morbidity in studies published prior and after the U.S. committee on Fetus and

Newborn updates on fetal viability threshold (from 28th to 22nd gestational weeks). This limitation is

addressed through utilizing obstetrical data published after the policy update (1995).

          Study strength: The vigor of this study is firstly and mostly in its multi-dimensional, and

country-based assessments of ethical debates and priorities. It also classifies maternal-fetal conflicts.

          VI. CONCLUSIONS: Patient's autonomy, adolescent's pregnancy, fetal surgery for nonlethal

reasons, posthumous dignity, cross-boarder reproduction, stem cell registry, and reproductive health in

mentally ill are the least attended ethical issues in reproductive health. Correlations fail to display

asociations between country-based ethical problems and maternal and perinatal mortality rates (r2 = 0.117-

0.209). Ethical principles are not equally discussed (Cochran's Q 65.08). 66.7% of abortion debates present

pro-choice, 6.7% pro-life, and 26.7% - balanced positions. 50% of studies present two or more ethical

principles. Beneficence and nonmaleficence are strongly associated (Pearson's chi 56.12, df = 1, p <

0.002).

          VII. IMPLICATIONS FOR RESEARCH: What is new in reproductive health ethics? A lot, but

not enough. An essential element of a good reproductive health study, or service delivery is that it be

performed in an ethical manner. In other words, ethics in medical practice and research operates as a

gatekeeper between what is legal, and what is not. Admitting and understaning ethical codes by both

patient and provider, may reduce        court-visited and ordered medical interventions. Unfortunatly,
                                                 Page 14 of 18

important barriers still remain in translating peculiar circumstances into meaningful improvement of

our understanding in reproductive health ethics. Further research should feature each ethical debate

with detailed observations of personal (ethnicity, education, marital and economic status), contextual

(public policy, health insurance limitations, cross-boarder health), and clinical (preexisting somatic/

mental conditions, genetic susceptibility, subject`s consentability and judgemental fit) factors that

contribute in ethical conflicts.

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Description: What is new in reproductive health ethics? A lot, but not enough. Ethical principles of public health are distinguishable from principles applied in modern bioethics. At the risk of over-simplifying the difference between clinical ethics and public health ethics, it could be said that the default position of clinical ethics centers on respect for the individual patient and his/her autonomy, whereas the default position of public health ethics centers on the pursuit of thecollective or common good. In other words, ethics in medical practice and research operates as a gatekeeper between what is legal, and what is not. Admitting and understaning ethical codes by both patient and provider, may reduce court-visited and ordered medical interventions.